Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn's disease. Issue 8 (28th February 2021)

• Record Type: Journal Article
• Authors: Goodsall, Thomas M.; Jairath, Vipul; Feagan, Brian G.; Parker, Claire E.; Nguyen, Tran M.; Guizzetti, Leonardo; Asthana, Anil K.; Begun, Jakob; Christensen, Britt; Friedman, Antony B.; Kucharzik, Torsten; Lee, Andrew; Lewindon, Peter J.; Maaser, Christian; Novak, Kerri L.; Rimola, Jordi; Taylor, Kirstin M.; Taylor, Stuart A.; White, Lauren S.; Wilkens, Rune; Wilson, Stephanie R.; Wright, Emily K.; Bryant, Robert V.; Ma, Christopher
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 53:Issue 8(2021)
• Page Start: 873
• Page End: 886
• Publication Date: 2021-02-28
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16288
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn's disease (CD). However, there is no widely accepted luminal disease activity index. Aims: To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. Methods: An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1‐9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. Results: A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. Conclusions: The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed. Abstract : This study employed a modified RAND/UCLA appropriateness methodology to define an evidence‐based approach to standardise IUS assessment of luminal CD activity and determine areas of uncertainty and inconsistency of practice. These results will be used to inform future studies whose ultimate goals include the development and validation of an IUS‐based CD activity score for implementation in clinical trials and clinical practice.